MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC. EARLOOP MASK PROCEDURAL L2; SURGICAL MASK

Model Number	GCPBL100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Local Reaction (2035)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Crosstex received a report from (b)(6), distributor of crosstex earloop procedural face masks, reporting 3 occurrences of rash which occurred after user facility personnel wore the reported face masks.Additionally, user facility personnel reported a "strong chemical odor." all symptoms were resolved after masks were removed and no further medical intervention was required.A device history review and retain testing on the reported lot were performed which identified no anomalies in the reported lot of product, including no noted chemical odor from the retain face masks.At this time, the complaint product has not been returned for investigation.In a review of complaints, no similar incidents have been reported on the crosstex earloop procedural face mask.Crosstex will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that when wearing the crosstex procedural earloop mask, 3 staff members noted rashes on their face and a "strong chemical smell." all symptoms were resolved by removing the mask.No further medical intervention was required and no further reports of harm or adverse reaction were reported from the facility.

• Brand Name: EARLOOP MASK PROCEDURAL L2
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 12475273
• Report Number: 2433773-2021-00003
• Device Sequence Number: 3779856
• Product Code: FXX
• UDI-Device Identifier: 10732224120383
• UDI-Public: 10732224120383
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: GCPBL100
• Device Catalogue Number: GCPBL100
• Device Lot Number: 20210125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1